This research project aims to identify a safer method of spinal anaesthesia for elderly patients undergoing surgical stabilisation of proximal femoral fractures.
The study's primary objective is to compare two spinal anaesthesia techniques: the continuous method (investigational), which allows titration of local anaesthetic doses through a catheter placed in the subarachnoid space, and the conventional single-shot bolus injection.
The main hypothesis is that the continuous catheter technique reduces the incidence of intraoperative hypotension and related complications, such as delirium, acute kidney injury, and cardiovascular events.
Beyond haemodynamic stability-assessed through advanced continuous monitoring of cardiac output and vascular resistance-the study will evaluate early and late complications, as well as quality of life up to 24 months post-surgery.
The project is a prospective, randomised, multicentre clinical trial including at least 216 patients over 50 years of age, randomly assigned to one of the two groups.
Proximal femoral fractures are a major and growing global health issue, particularly among geriatric patients with multiple comorbidities. The conventional single-shot spinal anaesthesia, though widely used, carries a high risk of hypotension, potentially leading to delirium, acute kidney injury, stroke, and cardiac events. These complications worsen prognosis, decrease quality of life, and increase mortality.
Most existing studies are over two decades old, based on small cohorts and outdated anaesthetic protocols, and lack long-term follow-up data (\>30 days) on neurological outcomes, functional recovery, quality of life, and mortality. Moreover, no modern trials have provided direct, comprehensive comparisons between single-shot and continuous spinal anaesthesia.
This project therefore seeks to fill this critical evidence gap through a robust randomised clinical trial. Using precise, continuous measurements of arterial pressure, vascular resistance, and cardiac output, alongside long-term assessments of neurological outcomes, quality of life, and survival, it aims to determine whether continuous spinal anaesthesia offers superior safety and should become the new standard of care for this vulnerable population.
Age > 50 years, regardless of gender
Diagnosis of a proximal femur fracture
Orthopedic qualification for open reduction and internal fixation of the fracture
Informed consent for the surgical procedure
Age < 50 years, regardless of gender
Refusal to consent to surgical treatment
Refusal to consent to regional anesthesia
Refusal to consent to participate in the study
Parallel
Bupivacaine Spinal 0,5% Heavy - bolus
DrugGroup 1 (Control Group) will receive single-shot spinal anesthesia with a bolus of 0.5% hyperbaric bupivacaine, with the dose adjusted according to the patient's weight and height to achieve a sensory block up to the T12 dermatome. The operating table will be kept in a neutral position.
Bupivacaine Spinal 0,5% Heavy - titration
DrugGroup 2 (Interventional Group) will receive continuous spinal anesthesia administered via a dedicated intrathecal catheter. An initial induction dose of 1 ml of 0.5% hyperbaric bupivacaine will be administered, followed by titrated boluses of 0.5 ml every 15 minutes until a sensory block to the T12 dermatome is achieved. Once the desired block height is established, the anesthetic level will be maintained by administering titrated doses of 0.5-1 ml approximately every hour. The operating table will be kept in a neutral position.
Mild hypotension
A comparison of frequency and duration of mild hypotensive episodes, defined as a 20% decrease in systolic arterial pressure (SAP) from the baseline value, between spinal anesthesia administered via catheter-based titration dosing (the investigational method) and single-shot administration (the conventional method)
Severe hypotension
A comparison of frequency and duration of severe hypotension episodes, defined as a decrease in systolic arterial pressure (SAP) of 30% from the baseline value
Hypotension associated with organ complications
Comparison of the incidence and duration of hypotensive episodes associated with organ complications, defined as a 50% decrease in mean arterial pressure (MAP) from the baseline value
Advanced hemodynamic measurements
A comparison of the incidence and duration of decrease or increase in the following hemodynamic parameters from their baseline values: cardiac index, CI \[ l/min/m²\] , stroke volume index, SVI \[ml/m²\], stroke volume variation index, SVV \[%\] , pulse pressure variation, PPV \[ %\], and systemic vascular resistance index, SVRI \[ dyn·s·cm-⁵/m²\]. The hemodynamic parameters will be indexed for body surface area
Bradycardia
Comparison of the incidence and duration of relative and absolute bradycardia, defined respectively as a heart rate (HR) below 60 and 40 beats per minute
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Centre of Postgraduate Medical Education
Lead sponsor
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Collaborator
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